European journal of heart failure · 2025
Heart failure outcomes captured by adverse event reporting in participants with type 2 diabetes and atherosclerotic cardiovascular disease: Observations from the VERTIS CV trial.
Клиническое исследование III фазыСтатьяМногоцентровое исследованиеРандомизированное исследованиеНазвание и аннотация: Перевод в очереди
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Pandey Ambarish, Kolkailah Ahmed A, McGuire Darren K, Frederich Robert C, Cater Nilo B, Cosentino Francesco, Pratley Richard E, Dagogo-Jack Samuel, Cherney David Z I, Wynant Willy, Gantz Ira, Mancuso James P, Masiukiewicz Urszula, Cannon Christopher P
Аннотация
AIMS: In VERTIS CV, ertugliflozin was associated with a 30% risk reduction for adjudication-confirmed, first and total hospitalizations for heart failure (HHF) in participants with type 2 diabetes and atherosclerotic cardiovascular disease. We evaluated the impact of ertugliflozin on the broader spectrum of all reported heart failure (HF) events independent of adjudication confirmation.
METHODS AND RESULTS: Data from participants who received ertugliflozin (5 or 15 mg) were pooled and compared versus placebo. HF events included all investigator-reported HF adverse events (AEs) and serious AEs (SAEs) based on the narrow standardized Medical Dictionary for Regulatory Activities (MedDRA) query 'cardiac failure'. Terms for orthopnoea, dyspnoea, and peripheral oedema were evaluated separately. The effect of ertugliflozin on the first HF event was assessed by Cox proportional hazard models. Total HF events were assessed by Andersen-Gill models to account for first and recurrent events. A total of 8238 participants received ≥1 dose of ertugliflozin or placebo (mean follow-up 3.5 years). Investigator-reported HF events and AE capture yielded 420 first and 627 total HF events (vs. 238 and 345 adjudication-confirmed HHF events, respectively, in the primary analyses). Ertugliflozin reduced the risk for first (hazard ratio [HR] 0.69; 95% confidence interval [CI] 0.57-0.84; p < 0.001) and total HF AEs (HR 0.66; 95% CI 0.57-0.78; p < 0.001), with similar results for first and total HF SAEs. Additionally, ertugliflozin reduced oedema risk, but not orthopnoea/dyspnoea.
CONCLUSION: The effect of ertugliflozin was consistent across the spectrum of total investigator-reported HF AEs and was similar in magnitude to adjudicated HHF events.
METHODS AND RESULTS: Data from participants who received ertugliflozin (5 or 15 mg) were pooled and compared versus placebo. HF events included all investigator-reported HF adverse events (AEs) and serious AEs (SAEs) based on the narrow standardized Medical Dictionary for Regulatory Activities (MedDRA) query 'cardiac failure'. Terms for orthopnoea, dyspnoea, and peripheral oedema were evaluated separately. The effect of ertugliflozin on the first HF event was assessed by Cox proportional hazard models. Total HF events were assessed by Andersen-Gill models to account for first and recurrent events. A total of 8238 participants received ≥1 dose of ertugliflozin or placebo (mean follow-up 3.5 years). Investigator-reported HF events and AE capture yielded 420 first and 627 total HF events (vs. 238 and 345 adjudication-confirmed HHF events, respectively, in the primary analyses). Ertugliflozin reduced the risk for first (hazard ratio [HR] 0.69; 95% confidence interval [CI] 0.57-0.84; p < 0.001) and total HF AEs (HR 0.66; 95% CI 0.57-0.78; p < 0.001), with similar results for first and total HF SAEs. Additionally, ertugliflozin reduced oedema risk, but not orthopnoea/dyspnoea.
CONCLUSION: The effect of ertugliflozin was consistent across the spectrum of total investigator-reported HF AEs and was similar in magnitude to adjudicated HHF events.